Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN HYDROCHLORIDE
B & S Healthcare
250 Milligram
Film Coated Tablet
2007-04-13
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PPA1328/074/001 Case No: 2029783 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CIPROXIN 250 MG FILM-COATED TABLETS The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 13/04/2007 until 12/04/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/04/2007_ _CRN 2029783_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciproxin 250 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 291.0mg ciprofloxacin hydrochloride equivalent to 250mg Ciprofloxacin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Italy:_ Film-coated tablet, round, white to slightly yellow, marked with Bayer cross on one side and ‘CIP’, a breakline and ‘250’ impressed on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin is indicated for the treatment of the following infections caused by sensitive bacteria: _ADULTS:_ _R Прочетете целия документ